12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/Carbodopa
Study Details
Study Description
Brief Summary
A 12-week, multicenter, double-blind, randomized study designed to evaluate the safety and efficacy of 20 and 60 mg/day istradefylline compared with placebo in subjects with OFF-time phenomena and advanced Parkinson's disease treated with levodopa/carbidopa.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- Change from Baseline to Endpoint in percentage of awake time per day in an OFF state based on the subjects' valid ON/OFF Parkinson's disease diary data. []
Secondary Outcome Measures
- Actual values and mean change from Baseline in percentage and total hours of awake time per day in the OFF state and ON state, UPDRS I-IV, II and III Scores during ON and OFF states, Global Clinical Impression-Improvement (CGI-I), safety []
Eligibility Criteria
Criteria
Inclusion Criteria:
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United Kingdom Parkinson's Disease Society brain bank diagnostic criteria (Steps 1 and 2).
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Modified Hoehn and Yahr in the OFF state of II-IV.
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Treated with levodopa/carbidopa for at least one year with a stable regimen for 4 weeks prior to randomization.
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Taking at least 4 doses of levodopa/carbidopa per day (3 doses if at least 2 doses contained slow-release formulation) with predictable end of dose wearing off.
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Successfully competed Parkinson's disease patient diary training with at least 120 minutes of OFF time per day.
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Stable regimen of other antiparkinson's medications for 4 weeks prior to randomization.
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At least 30 years of age and able to give written informed consent.
Exclusion Criteria:
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Treatment with liquid levodopa/carbidopa within 4 weeks of randomization.
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Treatment with MAO inhibitors except selegiline.
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Treatment within 3 months with centrally acting dopamine antagonists (6 months for depot formulations), e.g., antipsychotic neuroleptics, metoclopramide, buspirone, amoxapine.
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Neurosurgical operation for Parkinson's disease.
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Atypical parkinsonism or secondary parkinsonism variants.
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Diagnosis of cancer or evidence of continued disease within 5 years.
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Clinically significant illness of any organ system (e.g., ALT or AST > 1.5 times the upper limit of normal).
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Mini-Mental Status Examination score of 25 or less.
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History of drug or alcohol abuse or dependence within 2 years.
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History of psychotic illness or seizures.
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Clinically relevant depression disorder.
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History of neuroleptic malignant syndrome.
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Pregnancy or lactation. Women of child bearing potential must use a reliable method of contraception.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Contact Kyowa Pharmaceutical, Inc. | Princeton | New Jersey | United States | 08540 |
Sponsors and Collaborators
- Kyowa Kirin, Inc.
Investigators
- Study Director: Neil Sussman, MD, Kyowa Kirin, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6002-US-006